FDA's Actions on Pill Faulted

A GAO report bolsters charges that the agency bowed to politics over a 'morning-after' drug.

McClellan's successor as commissioner, Lester M. Crawford, said this summer that the agency needed more time to consider legal issues raised by requiring younger adolescents to have a prescription while allowing over-the-counter access for others. Crawford, who had promised the Senate a firm decision, resigned under pressure Sept. 23, for reasons still not fully explained.

"GAO found what parents would want: that the FDA handled a controversial drug with great caution," said Wendy Wright, executive vice president of Concerned Women for America, a conservative public policy organization that opposes making Plan B available without a prescription. "Making Plan B available over the counter would needlessly expose adolescents to risks.

"There are people within the FDA in those lower divisions who have absolutely no concern for adolescents," she continued. "Here, you have a corrective measure with the higher-ups saying, 'We need to be more responsible.' "

But Susan F. Wood, the former head of the FDA's office on women's health, said the GAO report showed that the agency had lost its independence.

"The decision was contrary to the evidence and contrary to the consensus that had been reached by all the review levels below," said Wood, who resigned Aug. 31 to protest the continued delays on Plan B.

"The process depends upon science and evidence to make decisions," she said. "The problem was not in the scientific review. There was a lot of agreement [by drug reviewers] on what the decision should have been. We all depend on this process to ensure that the FDA is doing its job."

Barr Laboratories had no comment on the GAO report, but said it would keep pressing for approval of over-the-counter sales.

The GAO said it found four areas in which the agency's handling of the 2004 Plan B decision was "unusual":

* The heads of the FDA offices that reviewed Barr's application -- Dr. Florence Houn, whose office deals with reproductive drugs, and Dr. Jonca Bull, responsible for over-the-counter medicines -- refused to sign the agency's decision because they disagreed with it. Dr. John Jenkins, director of the Office of New Drugs, also disagreed and did not sign the decision.

* High-level management was more involved in the decision than is usually the case for over-the-counter approvals, the GAO said.

* Investigators cited the conflicting accounts among mid-level and senior managers over whether the decision to reject the request was made before scientific evaluations had been completed.

* The rationale for shielding younger adolescents "was novel and did not follow FDA's traditional practices," the report said. In the past, the agency had not made age distinctions when it came to contraceptive use.

The GAO also found that the entire decision was "not typical" when compared to other cases involving requests for over-the-counter approval. From 1994 through 2004, the FDA approved 67 medications for sale without a prescription. Plan B was the only drug denied approval after an advisory committee recommended it.